Caplin Point Laboratories’ subsidiary -- Caplin Steriles (Caplin) has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Linezolid Injection 600mg/300mL (2mg/mL) Single-dose Infusion Bags, a generic therapeutic equivalent version of the Reference Listed Drug (RLD) ZYVOX from Pfizer Inc.
Linezolid Injection is an anti-bacterial primarily used to treat serious bacterial infections, including pneumonia and skin infections, particularly those resistant to other antibiotics. According to IQVIA (IMS Health), Linezolid Injection had US sales of approximately $23 million for the 12-month period ending October 2025.
Caplin Point Laboratories is the mid-sized company in India’s pharmaceutical sector to be engaged in the manufacture of APIs, finished formulations, research & development, clinical research, frontend generic presence in Latin America, brand marketing in Francophone Africa and an USFDA approved injectable facility.
